The primary aim was to assess the feasibility of using ambulance service practitioners to assess and deliver treatments for stroke in the ultra-acute setting after stroke. The secondary aim was to assess the effect of GTN use in ultra-acute stroke on safety, clinical, functional, and haemo-dynamic outcomes.

Objectives

Primary objectives

To report the proportion of randomised patients with a final diagnosis of ischaemic stroke, primary intra-cerebral haemorrhage, or transient ischaemic attack.

To assess the additional time taken by research paramedics for study related procedures prior to hospital admission.

To report the experiences, perceptions and challenges of a purposive sample of participating paramedics around facilitators and barriers to recruitment of study participants.

To assess the proportion of patients randomised and treated according to protocol.

To assess the characteristics of patients screened by the paramedics for inclusion to the RIGHT study.

Secondary objectives

To assess the safety and tolerability of GTN in suspected ultra-acute stroke.

To compare the difference in peripheral blood pressure, central blood pressure, heart rate, and its derivatives between patients randomised to GTN or no GTN.

To compare the difference between GTN and no GTN in death, disability, dependency, mood, cognition, and quality of life.

Methods

RIGHT is an ambulance-based, prospective, open label, single-blind, single city, randomised controlled trial with blinded outcome assessment.

Adult patients with suspected stroke presenting to research trained paramedics and fulfilling the study criteria were eligible for recruitment.

The study intervention is transdermal Glyceryl Trinitrate (GTN) patch (5 mg) or none (control). GTN is given in the form of Nitro-Dur 0.2 mg/hr (Schering-Plough Ltd) with the patch placed on the back or shoulder. Standard NHS supplies are used.

Semi-structured interviews were carried out with 14 paramedics around the process of recruitment. The interviews were transcribed verbatim, and analysed using thematic content analysis.

Outcomes

Primary outcomes

Comparison of systolic blood pressure at two hours post randomisation between GTN and no GTN groups. This outcome was chosen since it represents the sum of the trial feasibility and intervention, that is, the ability to identify, recruit, randomise, treat with GTN or control, and make measurements in patients with ultra-acute presumed stroke in an ambulance setting, and hand them over to hospital staff. The two hour time reflects the time to peak effect for GTN.

The RIGHT trial, the world’s first completed ambulance-based randomised controlled stroke trial, tested using GTN patches within 4 hours of a stroke by recruiting and treating 41 patients in the ambulance. This has led to funding by the British Heart Foundation of a definitive trial of prehospital GTN patches in ultra-acute stroke.